For joining today. Today we're going to start the 19 are to release webinar.
My name is Sharon land. I'm going to be the presenter today and I'm the principal Product Manager here at Walt CMS.
This is our product team. These of this product team here is responsible for all the features that you see here in 19 are to Tony size is going to help with my Q AMP. A so he's gonna be monitoring all the questions Mohammed will be on the call to to help if we have any coding questions.
And I want to find out that this presentation is only the outline divas general direction is only for informational purposes and is not intended to be any form of a contract. So the features are released at the sole discretion of Viva timeline.
Also the content of this presentation is subject to change. Prior to the 19 are to release. So please always review the help section for latest information about the release.
We want you to interact with us, and we encourage you to ask question Tony will be monitoring the questions, so please continue to ask questions and then we'll have a Q AMP a section at the end of the presentation.
So last year we announced that we were going to expand wall etc into a complete clinical data management solution and that included etc coding and data workbench.
They don't work benches, the repository that will help clean and manage all your study data. So it's not just etc but it will also include IE pro labs randomization imaging and so forth. So for enterprise accounts, you may be using five to seven different applications for your wall.
But what would we recommend is that you can move on to the wall CMS sweet and then you'll be able to save money toward data integration costs because that will be lowered what etc and Lot coding are available today. Beta workbench will be available in early 2020
Walt has three releases a year and the releases are April August and December and this is going to be our 19 are to believe that's happening in August.
So this is a release calendar and so important dates to remember is Monday the 22nd. That's when the pre release will be available on Tuesday, the 23rd validation docs are available and then everyone goes live on Friday, August 9
So in the pre release environment on the 22nd. This is what you're going to see when you log in. There will be a clone of the production in the UAE environment. That means all your data and configuration be copied on
The users are not copied on to the production pre release environment. And so, please contact your project manager so that you can add users to your pre release environment. The environment will be available up to four weeks after the 19 are to upgrade.
So on the 23rd your validation documents will be available and to get access to that you need to contact me the support to get login credentials and then you can access all of these docs.
So Friday, August 9 is our go live date. So that means everyone will be on the 19th are to release all the customers. Also the upgraded the EU starts at two o'clock Pacific time and in a pack in US starts at 5pm Pacific time and the upgrade may take up to six hours.
So all these resources that are talked about these important dates FAQs about the pre release the impact assessment, what's new in 19 are to all these resources are available in our CMS Help section.
So this is the agenda for today I'm going to talk about the investments that we made in CMS.
The nature are two features, how that was a value add to our customers. I'm gonna go to talk about the site features do a demo.
The features that were related to Siri and beta manager and I'm going to do a demo on that and then coder and then do a demo on that the final section after the presentations in a demo is our Q AMP a section and Tony's going to help with that.
So let's go ahead and get started.
So for 19 are two we've made a lot of investments in different areas to advance the CMS application.
I'm going to go into detail later about what what what we've done for sites for series for data managers and for coders, but I want to spend some time about admin and study designer, because we did make a lot of investments in that
Now you'll be able to configure a customized review plan and then assign that review plan to flights and case books.
We've also created this new slick user interface for creating customized study roles.
Also, if you have subjects that transfer from one site to another site due to relocation that will also be available. The coding configurations. You can configure coating on yourself now from us as a study designer.
But we also made investments in a feature. So we've created the foundation so that we will be able to release in the next couple releases clinical assessment quick buttons deployment and data workbench.
So now I want to talk about what we've done to add value to 19 are too we've optimized our user experience. We provide a feature so help clean your data.
We make data more accessible more targeted and more focused we improved our performance and we made some improvements, our dictionary search and we provided some better reporting.
We've also simple flied our user road management and we made some capabilities, where you can do instantaneous study changes faster site setup and the faster study bill.
So I want to talk about how our application works and how the features, how we access that
So we have different tabs in the application and in our data entry tab. That's where the sites will go in and enter all their
Data collection about the clinic for our Reviews tab. This is where all the reviews happen for our series and data manager, our coding tab. This is where a coding takes place. If you're an admin, you go into a section called etc tools and for study designers, they go into our study tab.
So before I go forward and talk about the individual features and my talk about the features. What you're going to see on the upper right hand corner. Are these icons.
And when you see these icons. This is what it means for each of the features. If you see a thumbs up. That's auto on that means when we go live on 90 are two, you're going to see that feature.
If you see this configuration icon on the upper left hand corner. That means that it requires some type of configuration. So if you don't see it. That means that it needs to be configured.
And then we also have this support icon and that means you need to call support and what we call it, we turn it on the wall level and for my needs to turn it on for your study itself.
And I'm going to go ahead and talk about what are the site's going to see when 19 are two is available.
So the first thing that we've done is we've added this feature called Casebook confirmation users can be able to confirm if they want to create a case book.
So what was happening is sites may accidentally create case books. So we want to make sure that this is what they want to do and will help minimize that error by asking for this confirmation
We've also added the capability to delete subjects. But you have to be granted permission. So as you can see, this is configurable. If you have the capability that means somebody assigned you that permission that you're able to do so.
This will give the swipes that story to correct any mistakes. They've made by adding a subject.
But there are considerations that you have to think about when you're deleting a subject. You can only delete a subject. If it has no data and it does have data, you have to delete the data first before you can delete the subject.
And this is only available in our new 19 our to security model.
We also allow unknown time. So previously, current or say currently what we do now is you can enter or configure and unknown months and day
And now you can also configure it so that you don't have to enter time. You can put a question mark in the time section and this is
Beneficial because patients sometimes don't remember when they have headaches and they require a question mark in there and sort of making it some inaccurate time
So we've also introduced this tabular data view where you see columns and rows for repeating item groups. So this is a nice view to have. So for example, if you have a form that's a medical history or physical exam. This tabular view is my society.
So what we've just talked about all the features that the sites are going to see some nightmares. Go ahead and demo it live. So let me pause this for one second while I get this environment setup.
Okay, so you should be able to see my screen. So I'm logged in as a fear see right now.
And if I click on new case book, what will happen is now that I get a confirmation and it asks do you are you sure you want to create this new Facebook. I click continue.
And then it creates a new case for. So now what I made a mistake. So now I have that permission, I can go ahead and delete it.
So you see this new area right here where it says delete subject, and you have to be granted his permission before you can go ahead and delete it. So I'm gonna go ahead and delete this subject, I'm gonna have to put a reason why
And I click on Continue.
And that case book is gone.
So the next thing I want to show you is that unknown time
So let's say I'm not sure of the time.
And going here.
And I go in here and edit this form. And you know what, I made a mistake and I received additional information and they really didn't know the time. Now I can go in here and add a question mark.
And then go ahead and save it. So now we allow for unknown time
So last thing I want to show you is that tabular view.
And so I have a physical exam for right here and it shows the view in this tabular format, whereas columns and rows. I can see the open queries. I can see respond to queries. If I click into it. I can also access my audit trail.
And I can also see if the data has changed. So these are things that your sites will be able to see when we, when we release 19 are too. So I'm going to stop the demo. And I'm going to continue on to our presentation.
Okay, so when we thought about is the trades. What's the site's going to see when 19 are two comes out. And now let's talk about the furious and data manager, what's the benefit that they're going to see when gets released
So the first thing is we've made data more accessible. So when you go into our review user interface that new review tab, you're going to see these new columns that were added.
Their last event and next event so shows when the last visit is the next visit. We've also we've also added a case book version so you can see what kids book version is on
We've enhanced our user experience so that when you're navigating on that tree on that visit informed and you're and you're rolling and scrolling down the right form side it will
It will be in sync right now and the left side will be highlighted. We're also allowing for form level reviews. We've also made intuitive icon changes. And we've also made that pop up screen when you view as a site, you can see that information, a lot better now.
We've also added a Save button. So any changes that you've done to the STV and a dear, dear Mr. It must be saved.
So this change happen because what we were seeing that if somebody clicks that check marks on the right hand too fast. It was sinking in appropriately for the statuses on the left hand side. So now you have to make those changes to the FTP or the EMR and you must click Save.
So I do want to talk briefly about that new review tab. So in 19 our one we released a new room of review tab.
And for traditional etc reviews for done on his era and Eva thought like, Well, what if we designed the user interface from scratch and made it specifically for series and data manager.
This is how the review tab was born. And it's consistent with Vivas culture of innovation. We want to do something that was specifically beneficial to our series and data manager.
So why would you use it because it's a more comprehensive view and focusing on reviews and instead of designing it for site entry.
You can easily navigate to the visit informs there's a centralized location for all your queries and reviews.
I'm going to show you that you can filter and you could show only the things that needs to be done and I can easily toggle between a site view and a monitor view. So if I'm not comfortable seeing from my view what data entry or MTV may look like I can switch to the site view.
So I'm going to go ahead and start the demo. So let me pause while I get that environment.
Okay, so I've logged on as a data manager and I'm going to go Access the site.
maximize my screen here. So what we've added here is this last event and this new event, I can go in here and hover and I, we've added that case book virgin. So we've made data more accessible. So once I click in here.
What you will see in this left. Now we made changes here. So these icons. These are status icons and before it made of look like it might be more clickable. So we've changed it to make it look more like status icons.
And so these cities have circles. That means work has not been done our half circles right here. That means that the work is incomplete these empty circles mean and it was not done. And these check marks mean that they were completely done
So if I want to come in today. And I want to just focus on the things that I need to do today. I can go ahead and click on this filter.
And you can see that the substance form went away because those forms were completed so any form that was completed, I can go ahead and just change that to that view. So it makes me focus on the things that I need to do today.
See, other things that we've added
There is this form capability right now that I can go ahead and review it at the form level. So if I click on here, you see all the changes that are made on here and at the same time as you can see anything that was not saved is now highlighted in yellow.
So another nice thing that we've done here is that when I go in here and I start scrolling down
You can see on the left hand side. So right now, you'll see that the demographics and physical exam or the darker blue and then when I start scrolling.
I go to the next form, it changes. So we meet the navigation so that it will sync. So as you're scrolling it coincides with what you're seeing on the left hand side.
These icons have also changed to make it noticeable that they are clickable. So if I want to go see once my Where's my next Open query. I click on that, it brings me to that query itself. I could go ahead and close that queries.
If I want to see where the next responded queries. I click on that.
I can also go in here and say what you know what I clicked on here. I'm going to go ahead and make sure that all of this is safe.
And as you can see, once I do those updates, what happens here. It gets updated here. So I'm gonna go ahead and show you that again. If I click on save.
That and I click on save all of this is upgraded for our demographics, so I can also go in here and check this task filter and it was showing me all the tasks that I need to do as my EMR.
So this view right here is really nice. And we specifically designed it for our series and data manager. So I encourage you to use this review tab.
Instead of the data entries that was made for sites. And if you do not see this review tab, please call your support and then we can turn that off for your wall.
So those are the features that we've done for our series and data managers. And now I'm going to go back to my presentation. So let me pause for a second.
Okay, so now I'm going to go ahead and go and talk about coding. Right. So what did we do for coding in 19 are two
So the first thing we've done is we've enhanced a user experience coders can select or deselect coding items in the coding listings panel. We've also moved the summary and this exposed or an icon to provide a cleaner look.
We've added a query status filter so that if I want to focus on the task at hand. I only want to see open queries or respond to queries.
I've also need the dictionary search more efficient. So when I'm searching for a drug name, but they have different preferred names all those will be grouped together on the top. I can search up to 10 keywords and I can, it can also now support special ASCII characters.
We've also added a dashboard that provides a graphical visualization of recording status and progress.
And we've also added a unique term report.
So those are the features that we've added for 19 RT for coding, but I'm going to go ahead and talk about the unique terms report. So, this report, you do have to call support to be able to get this report.
And what you're going to do is you can select the data rage and if you can see here that Asterix under the new term.
If there's an asteroid. That means that there was a new item that was flagged and it should be reviewed it is grouped by each unique term. So you see the record count for the each unique term. And we've also added a column where you can go ahead and add your comments.
So now I'm going to go into a live demo and then a pause and and get into the environment.
Okay, so I am login as a coder right now. And the first thing I'm going to show you is this select and D, select this is helpful. So let's say search on Advil
And instead of me clicking one at a time. I can now select all, and that gives me the convenience of not selecting one at a time. So I'm gonna go ahead and clear that
And I now want to be able to see you want, show me all my open queries. If I click on that, it will show only my open queries. So these are all options that I could choose from for the queries. So we've introduced a new query filter.
And now this section right here, this little IRA. Here we moved in our summary section to be over here. So if you want to see information about the form or about what therapeutic area. You just highlight this icon.
So now I'm going to go into the dictionary search. So, you know, you've used this yet, but this is nice. I can make this screen a lot bigger.
So I'm going to go into my dictionary surgeons talk about efficiencies that we've done here. If I enter light, a key.
And I do a search principle that right
Yes, I did. And it will include all the different preferred names group together on the top.
To know I'm going to show you. I'm going to cheat a little bit. I've been to a cut and paste and I want to show you
The searching you do any type of ASCII characters. So in here, you see I have dashes and I have period.
So I do a copy here.
I'm going to do a piece
And when I do a search
It searches and it reads that there are periods and there are dashes.
In the current release it will throw and let you know an error that hey, we don't recognize that character. So now we support these ASCII characters. And I also want to show you that pen keyword term search. Let me go ahead and get that screen.
So here are
10 terms you go ahead and paste this
And add it in here for search
And now go ahead and search that
For now, and added all these results because I can support the 10 key terms search
So that concludes the demos for series for data manager for coding and site. So these are all the features, you're going to see when 19 are two becomes available in August. Now we're going to go to our Q AMP. A and I'm going to ask Tony you pause for a second again.
Hey, Sharon. There is one question so far. So the question is what happens to the subject numbering. If you delete a subject is the subject number reusable.
One of the other subjects created before the mistaken subject is deleted. And the answer to that is that the subject number right now is is not reusable, so it will skip on to the next subject number
And and in the situation where, let's say you have, you know, if you're using or kind of default screening ID. If you're creating subjects like you know you have centers, one through 12345 and you deleted three. The next subject will be SCR 0006
However, if you're using a manual subject naming kind of override that will then override whatever that that that screening number that you have
This is a follow up question there. How does someone find a deleted subject and an audit trail. So there is a audit trail report.
That you can generate through a the audit trail job and that that's triggered in etc tools and in there, you will have a file for all deleted subjects.
So there, there's a in that job. It will create a individuals CSV file for every subject in the system with a full audit and they will also create a file for the deleted subject.
And and they'll preface the the naming of that that file with deleted and then subject ID study name site name and subjugating
And that that particular file will contain the full audit of that deleted subject.
Thank you, Tony. Is there any more questions.
I don't think we have another question, Tony.
Oh,
Yeah, another one just
Came in
Okay. The question is, his ability to lock data before the PII signs still being considered as a future update I asked because we have a recent case of a seer see deleting data, they should not have
So now, hold on, let me read the ability to lock EAT IT BEFORE THE P I said okay so the answer is, is no, because the lock will prevent any type of activities. However, if you freeze the data.
Before before signature that should prevent the the CRC from deleting any of the data. So if you freeze all the
All the forms or freeze entire Casebook
They won't be able to delete. However, they could still go inside.
Thanks, Tony. Is there any other question.
Okay. Well, I think that's it.
Thank you everyone for joining. Thank you for being a valued Viva customer. And this concludes our
Presentation. Thank you.